MAUDE Adverse Event Report: ST PAUL MEDFUSION 3000 SERIES; ACCESSORIES, PUMP, INFUSION

Catalog Number 67-2515-51

Device Problems Mechanical Problem (1384); Smoking (1585)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/01/2021

Event Type  malfunction  

Manufacturer Narrative

D4: udi is unknown.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).A product sample was received for evaluation.Visual and functional testing were performed.Visually inspected all batteries, plugged each battery in a test pump and charged for a few minutes, checked battery diagnostics.Detected no smoke or any damage.Only 1 out of 6 batteries had "battery not working" alarm occur with all battery values zero.The root cause of the reported issue could not be confirmed as the reported issue could not be replicated at the time of the device evaluation.Actions were taken to mitigate the reported issue: all 6 batteries were scrapped.

Event Description

It was reported that the batteries caused the machine smoke and wouldn't work.No patient injury reported.

• Brand Name: MEDFUSION 3000 SERIES
• Type of Device: ACCESSORIES, PUMP, INFUSION
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer (Section G): NULL
• Manufacturer Contact: jim vegel
• MDR Report Key: 16878281
• MDR Text Key: 314660511
• Report Number: 3012307300-2023-05203
• Device Sequence Number: 1
• Product Code: MRZ
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K091181
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/05/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 67-2515-51
• Device Lot Number: P0754077
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1